EU and the Swine Flu

May 28, 2009

Applied Clinical Trials

A look into how the European Union is handling the daunting health threats of the swine flu.

The EU has shown itself effective in the rapid response to the swine flu threat. From the outset, EU authorities have been in evidence, in consultation with the World Health Organization (WHO) on the one hand, and the pharmaceutical industry on the other.

On April 29, Health Commissioner Androulla Vassiliou met pharmaceutical industry representatives, in particular from vaccine manufacturers, to discuss questions on vaccines and antivirals. The talks covered how vaccines against the novel flu virus could be produced, both from a technical and a regulatory point of view, in the shortest time frame possible. EU officials are continuing to work with the industry to deliver on commitments to address the crisis.

The Czech Republic, currently the holder of the rotating six-month presidency of the EU, called an emergency meeting of health ministers, as Spain confirmed the first case of swine flu in Europe. The EMEA has also been holding talks with vaccine manufacturers. It has been preparing for a pandemic scenario since 2004, and has established a scientific and regulatory framework that can accommodate a range of different vaccine approval strategies.

There are currently six centrally approved marketing authorizations for vaccines, four of them specifically designed to be modified rapidly to incorporate a new pandemic strain, once it has been recommended by the WHO.

Here too, endorsement came from the EFPIA president. Higgins reported good cooperation with EU health officials and the WHO. “We have mechanisms in place to respond rapidly. We just need clear directions from the authorities,” he said. “We can cope, we have capacity, we are confident.” That may help reduce some of the stress in Europe right now.